FHR — Needle, Gastro-Urology Class I
FDA product code FHR covers "Needle, Gastro-Urology", a Class I medical device regulated under 21 CFR 878.4800. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- FHR
- Device Class
- Class I
- Regulation Number
- 878.4800
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K811965 | visitec | VISITEC NEEDLE RANGE (GASTERUROLOGY) | August 25, 1981 |